This study will be conducted in two parts: Part 1 will be conducted using a Dose Escalation and Expansion design. The Part 1 Dose Escalation Phase of this study will identify a safe and tolerable dose to be further evaluated in the Part 1 Dose Expansion phase. Part 2 of the study will be conducted in parallel with the Part 1 Dose Expansion Phase and will evaluate the safety and efficacy of CMP-001 when administered as a monotherapy. A Treatment Extension to assess the safety profile of CMP-001 when given in combination with pembrolizumab or as monotherapy will be available to those who are currently being treated in either Part 1 or Part 2 of this study at the time of protocol Amendment 9, v10.0.
Former Sponsor Checkmate Pharmaceuticals The primary objective of Part 1 of the study is to determine the recommended Phase 2 dose (RP2D) and schedule of CMP-001 when given in combination with pembrolizumab in participants with advanced melanoma. The primary objective of Part 2 of the study is to assess and describe the safety profile of CMP-001 when administered as monotherapy. The primary objective of the Treatment Extension is to assess the safety profile of CMP-001 when given in combination with pembrolizumab or as monotherapy in the Treatment Extension. Participants enrolled into either Part 1 or Part 2 will continue study treatment as long as they do not experience unacceptable toxicities and when continued treatment, is in the participant's best interest according to the Investigator. Participants may continue therapy beyond progression based upon Investigator judgement of potential benefit.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
199
CMP-001 will be administered as per the dose and schedule specified in the respective arms.
Pembrolizumab will be administered as per the schedule specified in the respective arms.
Banner MD Anderson Cancer Center
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
University of California, Los Angeles
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Georgetown
Washington D.C., District of Columbia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
...and 3 more locations
Part 1: Dose-Escalation Phase: RP2D of CMP-001 When Given in Combination With Pembrolizumab
Time frame: 21 days (for Schedule A dosing) and 35 days (for Schedule B dosing)
Part 2 Monotherapy: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs will be evaluated and assigned a grade using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From first dose of CMP-001 (Week 1 Day 1) until 30 days after the last CMP-001 injection (up to approximately 3.5 years)
Part 1 Dose Escalation and Dose Expansion: Number of Participants With TEAEs
TEAEs will be evaluated and assigned a grade using CTCAE version 5.0
Time frame: From first dose of CMP-001 (Week 1 Day 1) until 30 days after the last CMP-001 injection (up to approximately 3.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2 Monotherapy: Oral Temperature
Oral temperature should be measured in supine or seated position, following at least 30 minutes of rest.
Time frame: From screening up to end of treatment (EOT) (up to approximately 3.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2 Monotherapy: Respiratory Rate
Respiratory rate should be measured in supine or seated position, following at least 30 minutes of rest.
Time frame: From screening up to EOT (up to approximately 3.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2 Monotherapy: Systolic and Diastolic Blood Pressure
Blood pressure should be measured in supine or seated position, following at least 30 minutes of rest.
Time frame: From screening up to EOT (up to approximately 3.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2 Monotherapy: Body Weight
Physical examination included body weight measurement.
Time frame: From screening up to EOT (up to approximately 3.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2 Monotherapy: Body Mass Index (BMI)
Physical examination included BMI measurement.
Time frame: From screening up to EOT (up to approximately 3.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2 Monotherapy: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) Parameters
ECG parameters will include heart rate and PR, QRS, QT, and QT corrected for heart rate (QTc) intervals. QT will be corrected using Fridericia's (QTcF) formula. ECG will be performed after the participant has been resting in supine or semi-supine position for at least 5 minutes.
Time frame: From screening up to EOT (up to approximately 3.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2 Monotherapy: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters
Clinical laboratory parameters includes serum chemistry, hematology, and urinalysis.
Time frame: From screening up to EOT (up to approximately 3.5 years)
Part 1 Dose Escalation: Concentration of Chemokine IP-10
Time frame: Schedule A: Screening, Day 1 of Weeks 1, 3, 7, and Day 2 of Weeks 3, 7; Schedule B: Screening, Day 1 of Weeks 1, 5, 17, and Day 2 of Weeks 5, 17
Part 1 and Part 2: Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Using Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) Scans
ORR will be calculated as the number of participants with a confirmed complete response (CR) or partial response (PR) divided by the number of participants dosed.
Time frame: Baseline until confirmed disease progression (CR or PR) or death, whichever occur first (assessment at every 12 weeks throughout the study from Week 1 Day 1, up to approximately 3.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2 Monotherapy: Progression-Free Survival (PFS) as per RECIST Version 1.1 Using CT or MRI Scans
Time frame: From first dose of CMP-001 until disease progression or death, whichever occur first (assessment at every 12 weeks throughout the study from Week 1 Day 1, up to approximately 3.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2 Monotherapy: Best Overall Response (BOR) Rate (Percentage of Participants With Best Objective Response of CR or PR) as per RECIST Version 1.1 Using CT or MRI Scans
BOR will be calculated as the number of participants with best response of CR or PR divided by the number of participants dosed.
Time frame: Baseline until confirmed disease progression (CR or PR) or death, whichever occur first (assessment at every 12 weeks throughout the study from Week 1 Day 1, up to approximately 3.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2 Monotherapy: Time to Response (TTR) as per RECIST Version 1.1 Using CT or MRI Scans
Time frame: From first dose of CMP-001 until disease progression or death, whichever occur first (assessment at every 12 weeks throughout the study from Week 1 Day 1, up to approximately 3.5 years)
Part 1 Dose Escalation and Dose Expansion, and Part 2 Monotherapy: Duration of Response (DOR) as per RECIST Version 1.1 Using CT or MRI Scans
Time frame: From the date of first confirmed CR or PR until the first date of recurrent or progressive disease (assessment at every 12 weeks throughout the study from Week 1 Day 1, up to approximately 3.5 years)
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